Regulatory Affairs Professional

5 days ago


Copenhagen, Copenhagen, Denmark Oresund Pharma ApS Full time

We are seeking an experienced Regulatory Affairs Professional to join our team. In this role, you will be responsible for ensuring compliance with regulatory requirements and commercial demands worldwide.

As a key member of our Regulatory department, you will be the center of product maintenance activities, aware of your stakeholders, and understand the full value chain. You will focus on juggling and structuring various tasks, collaborating with both internal and external stakeholders to contribute to a good and open working environment.

You will play a fundamental role in helping shape processes and procedures to achieve timely and best practice regulatory life cycle management.

Key Responsibilities
  • Ensure compliance with regulatory requirements and commercial demands worldwide.
  • Prepare, review, and compile regulatory submissions.
  • Create product information (SmPC, labeling, and patient leaflets).
  • Monitor and set timelines for product maintenance, variations, and renewal approvals.
  • Stay up-to-date with national and international legislation, guidelines, and customer practices.


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